AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of its Ampligen drug as an intranasal therapy and reported no serious adverse events.
The company said the positive safety data paves the way for an escalation of the dose in Cohort 2 and is a critical step in its ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for coronavirus (COVID-19) and other respiratory viral diseases.
The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in The Netherlands, is conducting the clinical study AMP-COV-100. AIM ImmunoTech is sponsoring and funding the study.
READ: AIM ImmunoTech headed in 2021 with $54.4M in capital as it advances Ampligen to treat COVID-19 and cancer
The company said the study protocol calls for the enrollment of eight healthy subjects in each of four Cohorts to receive Ampligen. In addition, two healthy subjects in each Cohort will receive a placebo, for a total of 40 healthy subjects.
The subjects will also receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM ImmunoTech said this study will assess the safety, tolerability, and biological activity of repeated administration of Ampligen intranasally.
The company said the protocol design is for subjects in Cohort 1 to receive 75 micrograms (μg) of Ampligen or a matching placebo, Cohort 2 to receive 200 μg of Ampligen or a matching placebo, Cohort 3 to receive 500 μg of Ampligen or a matching placebo, and Cohort 4 to receive 1250 μg of Ampligen or a matching placebo.
“AIM is pleased with the positive results in this first cohort,” said AIM ImmunoTech CEO Thomas Equels in a statement. “This Phase 1 safety study is designed to test the parameters of Ampligen’s intranasal tolerance before commencing a Phase 2 study.
“While the higher doses that we plan to test in this Phase 1 trial may or may not be well tolerated, we plan on moving quickly into Phase 2 studies with the doses that have successfully passed these Phase 1 tests, such as the dose used in Cohort 1.”
AIM ImmunoTech said it will continue to provide interim updates on the clinical trial.
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Story by ProactiveInvestors
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